Sertraline 100mg tablets

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Sertraline hydrochloride

Boleh didapati daripada:

Kent Pharma (UK) Ltd

Kod ATC:

N06AB06

INN (Nama Antarabangsa):

Sertraline hydrochloride

Dos:

100mg

Borang farmaseutikal:

Oral tablet

Laluan pentadbiran:

Oral

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 04030300

Risalah maklumat

PATIENT INFORMATION LEAFLET: Information for the user
SERTRALINE HYDROCHLORIDE 100 MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet you may need to read it again.
•
If you have any further questions, please ask your doctor, pharmacist
or nurse.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.
•
If you get any of the side effects, talk to your doctor, pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET:
1. What Sertraline Tablets are and what they are used for
2. What you need to know before you take Sertraline Tablets
3. How to take Sertraline Tablets
4. Possible side effects
5. How to store Sertraline Tablets
6. Contents of the pack and other information
1. WHAT SERTRALINE TABLETS ARE AND WHAT THEY ARE USED FOR
Sertraline Tablets contain the active substance Sertraline. Sertraline
Tablets is one of a group of medicines called
selective serotonin reuptake inhibitors (SSRIs). These work by
bringing the level of serotonin in the brain, back up
to normal. Low levels of serotonin are thought to be a cause of
depression and related disorders.
Sertraline can be used to treat:
•
Depression and prevention of recurrence of depression in adults
•
Social anxiety disorder in adults
•
Obsessive-compulsive disorder (OCD) in adults, children and
adolescents aged 6 – 17
•
Post traumatic stress disorder (PTSD) in adults
•
Panic disorder in adults
Depression is a clinical illness with symptoms like feeling sad,
unable to sleep properly or to enjoy life as you used to.
OCD and Panic disorders are illnesses linked to anxiety with symptoms
like being constantly troubled by persis-
tent ideas (obsessions) that make you carry out repetitive rituals
(compulsions).
PTSD is a condition that can occur after a very emotionally traumatic
experience and has some sy

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sertraline 100mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg of sertraline (as
hydrochloride).
Excipient(s) with known effect:
Each film-coated tablet contains 87.42 mg lactose (as monohydrate) and
1.34
mg (0.058 mmol) sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, capsule shaped tablet scored on one side.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sertraline is indicated for the treatment of:
Major depressive episodes. Prevention of recurrence of major
depressive episodes.
Panic disorder, with or without agoraphobia.
Obsessive compulsive disorder (OCD) in adults and paediatric patients
aged 6-17
years.
Social anxiety disorder.
Post traumatic stress disorder (PTSD)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Initial treatment _
_Depression and OCD _
Sertraline treatment should be started at a dose of 50 mg/day.
_Panic Disorder, PTSD, and Social Anxiety Disorder _
Therapy should be initiated at 25 mg/day. After one week, the dose
should be
increased to 50 mg once daily. This dose regimen has been shown to
reduce
the frequency of early treatment emergent adverse reactions
characteristic of
panic disorder.
_Titration _
_Depression, OCD, Panic Disorder, Social Anxiety Disorder and PTSD _
Patients not responding to a 50 mg dose may benefit from dose
increases.
Dose changes should be made in steps of 50 mg at intervals of at least
one
week, up to a maximum of 200 mg/day. Changes in dose should not be
made
more frequently than once per week given the 24-hour elimination half
life of
sertraline.
The onset of therapeutic effect may be seen within 7 days. However,
longer
periods are usually necessary to demonstrate therapeutic response,
especially
in OCD.
_Maintenance _
Dose during long-term therapy should be kept at the lowest effective
level,
with subsequent
adjustment depending